Ozone Therapy in Ankylosing Spondylitis

Not Applicable

Completed

• Conditions: Ankylosing Spondylitis
• Interventions: Other: Ozone therapy

• Registration Number: NCT05429801
• Lead Sponsor: Pamukkale University

Brief Summary

The aim of this study was to investigate the effects of rectal ozone therapy added to medical treatment on pain severity, disease activity, spinal mobility, functional status, enthesitis, and quality of life (QoL) in patients with ankylosing spondylitis (AS).

Patients and methods: Patients who fulfilled the modified New York criteria for AS were included in this randomized controlled study. Thirty patients selected according to inclusion and exclusion criteria were randomized into two groups. Rectal ozone treatment along with medical treatment was administered to the patients in group 1, in increasing doses for 5 sessions per week, 20 sessions in total for 4 weeks. The patients in group 2 continued only their current medical treatment. All patients received a comprehensive rheumatologic assessment including pain severity, disease-specific instruments for disease activity, functional status, spinal mobility, enthesitis score, and QoL.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-01
• Primary Completion: 2019-07-01
• Study Completion: 2019-12-30
• Status Verified: 2022-06
• Study First Submitted: 2022-06-13
• Study First Submitted QC: 2022-06-22
• Last Update Submitted: 2022-06-22
• Study First Posted: 2022-06-23
• Last Update Posted: 2022-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patients who were diagnosed as AS according to the Modified New York criteria

Exclusion Criteria

• having other concomitant rheumatic diseases,
• receiving anti-TNF-α therapy within the last 3 months,
• being in clinical remission with standard medical treatment,
• being pregnant,
• having diseases such as favism, asthma, pancreatitis, and uncontrolled hyperthyroidism for which ozone therapy is contraindicated.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ozone Therapy	Ozone therapy	Rectal ozone treatment along with medical treatment was administered to the patients in this group, in increasing doses for 5 sessions per week, 20 sessions in total for 4 weeks.
Control group	Ozone therapy	The patients in this group continued only their current medical treatment.

Primary Outcome Measures

Name	Time	Method
visual analogue scale (VAS)	Change from baseline VAS at the 4th week after the treatment	The patients were assessed for low back pain level according to the 10 cm visual analogue scale (VAS) from 0 (no pain) to 10 (maximum pain).

Secondary Outcome Measures

Name	Time	Method
Bath Ankylosing Spondylitis Disease Activity Index	Change from baseline Bath Ankylosing Spondylitis Disease Activity Index at the 4th week after the treatment	Bath Ankylosing Spondylitis Disease Activity Index was used to assess disease acticvity.The Bath Ankylosing Spondylitis Disease Activity Index has a range of 0 to 10; a lesser number represents less severe disease activity
Ankylosing Spondylitis Disease Activity Score	Change from baseline Ankylosing Spondylitis Disease Activity Score at the 4th week after the treatment	Ankylosing Spondylitis Disease Activity Score is a new composite index to assess disease activity which contains low back pain, global assessment of the patient, peripheral joint pain and swelling, duration of morning stiffness, and acute phase response parameters.Four disease activity states were chosen by consensus: inactive disease, moderate, high, and very high disease activity. The three cut-offs selected to separate these states were: 1.3, 2.1 and 3.5 units. Hihger score means higher disease activity.
Bath Ankylosing Spondylitis Functional Index	Change from baseline Bath Ankylosing Spondylitis Functional Index at the 4th week after the treatment	The Bath Ankylosing Spondylitis Functional Index (BASFI) was used to determine the degree of functional limitation in patient with AS. The Bath Ankylosing Spondylitis Functional Index has a score between 0 and 10, with a higher score indicating more functional limitation
Ankylosing Spondylitis Quality of Life	Change from baseline Ankylosing Spondylitis Quality of Life score at the 4th week after the treatment	The disease-specific instrument Ankylosing Spondylitis Quality of Life (ASQoL) includes 18 yes or no questions related to the impact of disease on sleep, mood, motivation, coping, activities of daily living, independence, relationships, and social life with a total score of 0-18. Lower ASQoL scores represent a better QoL

Trial Locations

Locations (1)

Hakan Alkan; 🇹🇷 Denizli, None Selected, Turkey